EMERGENCY USE AUTHORISATION

Subject : Governance

Context :Three vaccine developers have sought emergency use approval while their candidates are still in trials. India’s regulations provide for ‘accelerated approval’ in special situations.

Concept :

Regular procedure for drug approval:

• Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of a regulatory authority before they can be administered.
• In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).
• For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials.

When can emergency use authorisation (EUA) be granted?

• In the US, the Food and Drug Administration (FDA) grants EUA only after it has been determined that the “known and potential benefits outweigh the known and potential risks of the vaccine” (or medicine).
• This means that a EUA application can be considered only after sufficient efficacy data from phase 3 trials had been generated.
• A EUA cannot be granted solely on the basis of data from phase 1 or phase 2 trials.

What is the process of getting an emergency use authorisation in India?

• Experts and activists say India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined or consistent.
• Despite this, CDSCO has been granting emergency or restricted emergency approvals to Covid-19 drugs during this pandemic for remdesivir and favipiravir.

Is there a risk in using a product that has only been granted an EUA?

• According to the US FDA, the public has to be informed that a product has only been granted an EUA and not full approval.
• In the case of a Covid-19 vaccine, for example, people have to be informed about the known and potential benefits and risks, and the “extent to which such benefits or risks are unknown”, and that they have a right to refuse the vaccine.